Effective IMPD Writing. The Quality Part

Webinar: Effective IMPD Writing. The Quality Part

Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is required by competent authorities in EU.

The purpose of this webinar is to share the best practices in the preparation of IMPD in order to meet the expectations of competent authorities and to learn why effective CMC technical writing is crucial for the development of a high quality IMPD.

You will learn about:

1. Regulatory guidelines for the Investigational Medicinal Product Dossier

2. IMPD structure and content

3. Best practices for the preparation of IMPD

Best practices in IMPD Quality writing;
Writing style to produce accurate, concise, and clear technical text.

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Who should attend? Professionals from the following fields:

Regulatory
R&D
QA/QC
Compliance
Product Development
Manufacturing

Duration: 40 min.

Speakers:

Head of the Central Functions for Regulatory Affairs, Ramunė Rūkienė;
Medical Writer, Eglė Deimantavičiūtė.

Ramunė Rūkienė, MSc

Head of Regulatory Affairs Central Operations

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Effective IMPD Writing. The Quality Part

Webinar: Effective IMPD Writing. The Quality Part

1. Regulatory guidelines for the Investigational Medicinal Product Dossier

2. IMPD structure and content

3. Best practices for the preparation of IMPD

Starting Clinical Trials?

Ramunė Rūkienė, MSc

Other content that might interest you:

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Drugs serialization and barcoding in Saudi Arabia and MENA region

eCTD implementation across MENA region: What is the current status?

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

Biomapas appoints Director Regulatory Affairs

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Effective IMPD Writing. The Quality Part

Webinar: Effective IMPD Writing. The Quality Part

1. Regulatory guidelines for the Investigational Medicinal Product Dossier

2. IMPD structure and content

3. Best practices for the preparation of IMPD

Starting Clinical Trials?

Ramunė Rūkienė, MSc

Other content that might interest you:

eCTD Submission Strategies: In-house vs. Outsourcing

Drugs serialization and barcoding in Saudi Arabia and MENA region

eCTD implementation across MENA region: What is the current status?

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

Biomapas appoints Director Regulatory Affairs

The Predicted Impact of the ISO IDMP Standards Implementation Process Carried Out by the European Medicines Agency

Big Enough To Cover All Your Needs. Small Enough To Care.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

Clinical Trials

PV System & QPPV

Post-Authorization

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Small Enough To Care.